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RECRUITINGPhase 2INTERVENTIONAL

A Study With CIT-013 in RA Patients

A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA. Participants will: Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening - Aged 18-85 - DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization - Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months. Who Should NOT Join This Trial: - High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD). - Contra-indication for CIT-013 - Current inflammatory joint disease other than RA (Sjogren with active disease is included). - The waiting period after previous treatment for bDMARD or JAKi prior to the first dose of investigational product should be at least: 1. ≥ 1 week for etanercept; 2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; 3. ≥ 6 months year for rituximab; 4. ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment). - Treated with ≥ 3 bDMARD or tsDMARD - Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening * Aged 18-85 * DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization * Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months. Exclusion Criteria: * High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD). * Contra-indication for CIT-013 * Current inflammatory joint disease other than RA (Sjogren with active disease is included). * The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least: 1. ≥ 1 week for etanercept; 2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; 3. ≥ 6 months year for rituximab; 4. ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment). * Treated with ≥ 3 bDMARD or tsDMARD * Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.

Treatments Being Tested

DRUG

CIT-013 low dose

Subcutaneous injection

DRUG

CIT-013 high dose

Subcutaneous injection

DRUG

Placebo

Subcutaneous injection

DRUG

CIT-013 medium dose

CIT-013 medium dose

Locations (20)

BE-02
Antwerp, Belgium
Site BE-01
Leuven, Belgium
DE-04
Bamberg, Germany
DE-05
Berlin, Germany
DE-01
München, Germany
DE-02
München, Germany
DE-03
Ratingen, Germany
NL-02
Amsterdam, Netherlands
NL-05
Leeuwarden, Netherlands
NL-04
Leiden, Netherlands
NL-03
Nijmegen, Netherlands
NL-01
Rotterdam, Netherlands
PL-01
Bialystok, Poland
PL-07
Krakow, Poland
PL-03
Lublin, Poland
PL-02
Poznan, Poland
PL-05
Torun, Poland
PL-04
Warsaw, Poland
ES-02
A Coruña, Spain
ES-04
Barcelona, Spain